Recruiting

cNIBP & Oscillometric

Sponsor:

Becton, Dickinson and Company

Code:

NCT07216573

Conditions

Blood Pressure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors

Study Details

Brief summary:

A before and after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure (cNIBP) measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting.

Conditions

Blood Pressure

Study ID

NCT07216573

Start date

May 7, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Signed informed consent
2. Age ≥ 18 years
3. American Society of Anesthesiologists (ASA) Physical Status ≥ 2
4. Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff

Exclusion Criteria:

1. Patient who is known to be pregnant
2. Patient with existing or planned arterial pressure catheter
3. Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms
4. Inability to place oscillometric cuff on the subject's upper extremity
5. Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
6. Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
7. Inability to place finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)

Study Design

Enrollment

188 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cohort 1 - Standard of Care

Study device data are blinded to the provider

experimental: Cohort 2 - Standard of Care with cNIBP Monitoring

Study device continuous non-invasive blood pressure data are unblinded to the provider

Interventions

HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors

Devices are applied for monitoring throughout the duration of the procedure

Primary outcome measure

  • Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a mean arterial pressure (MAP) < 65 mmHg, for a total duration of at least 5 minutes. [ Time Frame: Through Study Completion, approximately 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14620

More Information

Sponsor

Becton, Dickinson and Company

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Becton, Dickinson and Company on 2026-07-08.